Trial Outcomes & Findings for Palliative Care for Non-Malignant Diseases (COMPASS Trial) (NCT NCT03022630)

NCT ID: NCT03022630

Last Updated: 2019-11-22

Results Overview

Assess the impact of palliative care services on time to first hospital readmission. Time frame was changed from 1 year to 6 months due to early termination.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: 6 months post-randomization
• Results posted on: 2019-11-22

Participant Flow

Participant milestones

Measure	Comprehensive Palliative Care Services Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Overall Study STARTED	31	32
Overall Study COMPLETED	22	20
Overall Study NOT COMPLETED	9	12

Reasons for withdrawal

Measure	Comprehensive Palliative Care Services Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Overall Study Death	9	7
Overall Study Withdrawal by Subject	0	5

Baseline Characteristics

Palliative Care for Non-Malignant Diseases (COMPASS Trial)

Baseline characteristics by cohort

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=32 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.	Total n=63 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 12.3 • n=5 Participants	56.8 years STANDARD_DEVIATION 9.4 • n=7 Participants	56 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	31 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	32 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-randomization

Population: 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.

Assess the impact of palliative care services on time to first hospital readmission.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Time to First Hospital Readmission Within 6 Months Post-randomization	117 days Interval 44.0 to NA is due to censoring for death and withdrawals.	68 days Interval 22.0 to NA is due to censoring for death and withdrawals.

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.

Days alive out of hospital from randomization to 6 months post randomization compared across arms.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Days Alive Out of Hospital	174 days Interval 59.5 to 183.0	178 days Interval 86.5 to 182.5

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.

Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Total Days in Hospital	1 days Interval 0.0 to 10.5	3 days Interval 0.0 to 5.5

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.

Total days in ICU from randomization to 6 months post randomization compared across arms.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Total Days in ICU 0 ICU days	26 Participants	23 Participants
Total Days in ICU 1 ICU days	2 Participants	1 Participants
Total Days in ICU 2 ICU days	1 Participants	2 Participants
Total Days in ICU 6 ICU days	1 Participants	0 Participants
Total Days in ICU 7 ICU days	0 Participants	1 Participants
Total Days in ICU 9 ICU days	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.

Number of hospital readmissions from randomization to 6 months post randomization compared across arms.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Number of Hospital Readmissions 0 readmissions	15 Participants	11 Participants
Number of Hospital Readmissions 1 readmission	9 Participants	8 Participants
Number of Hospital Readmissions 2 readmissions	3 Participants	5 Participants
Number of Hospital Readmissions 3 readmissions	1 Participants	2 Participants
Number of Hospital Readmissions 4 readmissions	2 Participants	1 Participants
Number of Hospital Readmissions 5 readmissions	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: The sample size indicates number of hospital readmissions per study arm.

Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=28 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Median Length of Hospital Stay Per Admission	4 days per admission Interval 2.0 to 6.0	2.5 days per admission Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: 5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.

Number of transfers to hospice within 6 months post randomization compared across arms.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Hospice Referral	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.

Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.

Outcome measures

Measure	Comprehensive Palliative Care Services Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=3 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Time to Hospice Placement 4.36 days	—	1 Participants
Time to Hospice Placement 2.78 days	—	1 Participants
Time to Hospice Placement 143.84 days	—	1 Participants

SECONDARY outcome

Timeframe: Change from baseline over 6 months post-randomization

Population: Only 5 participants in each group returned both the baseline and 6-month surveys.

Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is "present always" while a score of 7 means the symptom is "never present". Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=5 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=5 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Change in Chronic Liver Disease Questionnaire (CLDQ)	0.52 score on a scale Interval 0.34 to 1.41	0.34 score on a scale Interval -0.1 to 0.7

SECONDARY outcome

Timeframe: Change from baseline over 6 months post-randomization

Population: Only 5 participants from each group returned both baseline and 6-month surveys.

Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=5 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=5 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Change in EQ-5D-5L	21 score on a scale Interval -5.0 to 31.0	-1 score on a scale Interval -7.0 to 20.0

SECONDARY outcome

Timeframe: Change from baseline over 6 months post-randomization

Population: Only 5 participants from each group returned both baseline and 6-month surveys.

Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=5 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=5 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Change in PROMIS Emotional Distress - Anxiety - Short Form 4a	0 score on a scale Interval -1.0 to 0.0	0 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Change from baseline over 6 months post-randomization

Population: Only 4 participants from the comprehensive palliative care services each group and 5 participants from the usual hepatic care group returned both baseline and 6-month surveys.

Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=4 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=5 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Change in PROMIS Emotional Distress - Depression - Short Form 4a	-4 score on a scale Interval -7.95 to -2.17	-3.2 score on a scale Interval -3.5 to 1.9

SECONDARY outcome

Timeframe: Change from baseline over 6 months post-randomization

Population: Only 5 participants from the comprehensive palliative care services each group and 4 participants from the usual hepatic care group returned both baseline and 6-month surveys.

Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=5 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=4 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)	0 score on a scale Interval 0.0 to 3.25	0.8 score on a scale Interval -0.91 to 1.96

SECONDARY outcome

Timeframe: Change from baseline over 6 months post-randomization

Population: The intended population included caregivers. There is no statistics to report. The two scores from participants in the intervention group are indicated below.

The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=2 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Change in Kingston Caregiver Stress Scale Change in Kingston Caregiver Stress Scale Score:15	1 Participants	—
Change in Kingston Caregiver Stress Scale Change in Kingston Caregiver Stress Scale Score:7	1 Participants	—

SECONDARY outcome

Timeframe: Change from baseline over 6 months post-randomization

Population: The intended population includes the caregivers. Only one caregiver in each group returned both surveys.

Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=1 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=1 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)	0 score on a scale Interval 0.0 to 0.0	-2.83 score on a scale Interval -2.83 to -2.83

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: Liver transplant status data was not obtained.

Number of deferred, listed, and declined listing for liver transplant compared across arms.

Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Baseline MELD scores were only available for 26 intervention group participants and 27 control group participants.

Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant.

Outcome measures

Measure	Comprehensive Palliative Care Services n=26 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Model for End-Stage Liver Disease (MELD) Score	24 score on a scale Interval 20.0 to 26.0	24 score on a scale Interval 17.5 to 28.0

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: 5 participants withdrew from the usual hepatic care group.

Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Completed Liver Transplants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: Physical symptom data was not obtained.

Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms.

Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: 5 participants withdrew from the usual hepatic care group.

Percentage of patients with documented advance care directives compared across arms.

Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Presence of Advance Directives	25 Participants	23 Participants

SECONDARY outcome

Timeframe: 6 months post-randomization

Population: 5 participants withdrew from the usual hepatic care group.

Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination.

Outcome measures

Measure	Comprehensive Palliative Care Services n=31 Participants Comprehensive Palliative Care services in addition to usual hepatic care Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.	Usual Hepatic Care n=27 Participants Usual hepatic care Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
Survival	22 Participants	20 Participants

SECONDARY outcome

Timeframe: Change from Baseline to study closeout.

Population: The provider population was not analyzed because data was not collected.

The "ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor" instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35.

Time frame was changed due to early termination. Data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Comprehensive Palliative Care Services

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Usual Hepatic Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cheryl Gatto

Vanderbilt University Medical Center

Phone: 6153432252

Email: cheryl.l.gatto.1@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place